Advin Multi-Drug Screen Test
AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
16manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (9), Guangdong (3), Beijing (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Biotest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 41 |
| Abon Biopharm (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Core Technology Co., Ltd. | Changping District | Beijing | Contract manufacturer | 14 |
| Prometheus Bio Inc. | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou AllTest Biotech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Guangzhou Wondfo Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 44 |
| W.h.p.m. Bioresearch & Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 37 |
| Guangzhou Decheng Biotechnology Co., Ltd. | Guangzhou | Guangdong | Complaint-file establishment | 35 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Co-Innovation Biotech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 29 |
Showing 12 of 16. All 16 manufacturers in China registered for Enzyme Immunoassay, Amphetamine
Record
| Listed by | Advin Biotech, Inc., United States |
|---|---|
| FDA product code | DKZ |
| Device type | Enzyme Immunoassay, Amphetamine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.3100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2020-08-26 |
| Record revised | 2025-08-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 30 °C |
| Distribution end date | 2030-07-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ABCup-05-51 | 25 | In distribution | |
| 1 | 25 | In distribution | |
| ABCupC-14-01 | 25 | In distribution | |
| ABCard-07-46 | 25 | In distribution | |
| ABCupA-06-15 | 25 | In distribution | |
| 1 | 25 | In distribution | |
| ABCard-09-35 | 25 | In distribution | |
| ABCardA-11-25 | 25 | In distribution | |
| ABCard-01-AMP500 | 25 | In distribution | |
| ABCard-12-71 | 25 | In distribution | |
| ABCupC-10-13 | 25 | In distribution | |
| ABCup-09-35 | 25 | In distribution | |
| ABCupC-12-71 | 25 | In distribution | |
| 1 | 25 | In distribution | |
| 1 | 25 | In distribution | |
| ABCup-07-46 | 25 | In distribution | |
| ABCard-05-51 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Healgen | Healgen Scientific Limited Liability Company | 69 |
| First Sign® | Hemosure Inc. | 39 |
| DrugCheck | Express Diagnostic Int’l, Inc. | 38 |
| DrugCheck | Express Diagnostics Int’l., Inc. | 21 |
| T-Square | Wondfo USA Co., Ltd. | 15 |
| Enzyme Immunoassay, Amphetamine | W.h.p.m., Inc. | 15 |
| Statcup® II | Micro Distributing, L.C | 12 |
| MD DugScreen | Medical Disposables Corp | 12 |
| QuickProfile™ Drugs of Abuse Test Cup | Lumiquick Diagnostics, Inc. | 11 |
| Noble Drug Test Cup (Urine) | Noble Medical Inc | 10 |
| ECO II Cup ® | W.h.p.m., Inc. | 10 |
| UCP Home Drug Screening Test Cups | UCP Biosciences, Inc. | 9 |
Showing 12 of 223. All products under Enzyme Immunoassay, Amphetamine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122809 | 2013-06-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.